| Device |
parathyroid autofluorescence detection device |
| Regulation Description |
Autofluorescence detection device for general surgery and dermatological use. |
| Definition |
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis. |
| Physical State |
The device has a patient contacting fiber optic probe connected to a console with a coherent excitation light source in the near infrared spectrum. The device is used to capture autofluorescence signals of the target tissues. Imaging contrast agents are not required for autofluorescence detection. |
| Technical Method |
The device is a patient contacting device that quantifies the ratio of autofluorescence of parathyroid to thyroid tissue using a coherent excitation light source in the near infrared spectrum. |
| Target Area |
Parathyroid glands. |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | QDF |
|---|
| Premarket Review |
General Surgery Devices
(DHT4A)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4550
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
